MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number	150600003
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a aseptic loosening of the right tibial tray at the cement to implant interface, resulting in pain and necessitating revision surgery with explantation of the device.The cement used was not manufactured by depuy synthes.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: there is no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Added: d10 (concomitant).
Additional Manufacturer Narrative
Corrected information: follow up 2 of (b)(4) was not reported late.The g3.Date received by manufacturer was incorrectly reported within (b)(6) 2026 of (b)(4).The correct date is (b)(6) 2026, which makes the report submission due date to be (b)(6) 2026.
Event or Problem Description
Additional information received: 1.Please confirm the manufacturer for the cement product and also for the quantity used.Hug are palacos users.2.Is there any allegation against attune ps fb insrt sz 4 8mm and attune ps fem rt sz 4 cem? no allégations against the pe or the fémoral implant.(b)(6)created.
Additional Manufacturer Narrative
Product complaint #(b)(4) investigation summary = > no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot = > there is no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Added: b5.

• Brand Name: ATTUNE
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24757478
• Report Number: 1818910-2026-05672
• Device Sequence Number: 21025664
• Product Code: JWH
• UDI-Device Identifier: 10603295042372
• UDI-Public: (01)10603295042372(17)270331(10)8510253
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 150600003
• Device Lot Number: 8510253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/06/2026; 04/15/2026; 04/17/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/07/2026; 04/17/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE PS FB INSRT SZ 4 8MM.; ATTUNE PS FEM RT SZ 4 CEM.; UNK BONE CEMENT (COMPETITOR).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female